Paragastric Autonomic Neural Blockade as Part of Combined Anesthesia.

Not Applicable

Completed

• Conditions: Anesthesia Morbidity; Opioid Use
• Interventions: Other: PG-ANB performed at the outset of LSG; Other: PG-ANB performed at the end of the LSG

• Registration Number: NCT05668845
• Lead Sponsor: Universidad Simón Bolívar

Brief Summary

To evaluate the effect of early autonomic blockade on the consumption of remifentanil and halogenated anesthesia in the intraoperative period during laparoscopic sleeve gastrectomy.

Detailed Description

Balanced general anesthesia, even if combined with local anesthesia or parietal blocks such as transversus abdominis plane (TAP), subcostal, or pararectal blocks, is insufficient to block the autonomic impulses released during most intra-abdominal visceral surgeries, especially in laparoscopic sleeve gastrectomy (LSG). These impulses are, in part, responsible for the hemodynamic changes observed during different phases of LSG and the subsequent visceral pain and associated symptoms, such as nausea and vomiting, observed in a substantial number of patients in the immediate postoperative period after LSG and other minimally invasive procedures. Visceral pain substantially impacts patients' quality of life, recovery time, nursing time allocation, and resultant risk of opioid abuse. Nausea, food intolerance, and pain are responsible for most readmissions after LSG and other bariatric procedures. Many of these patients have associated severe respiratory impairments and other comorbidities. They often need increased amounts of halogenated anesthetics, opioid analgesics, antiemetics, and other anesthetic modalities such as epidural anesthesia. A recent randomized clinical trial (RCT) demonstrated that a novel approach, namely paragastric autonomic neural blockade (PG-ANB), is safe and effective in addressing visceral pain while reducing the need for analgesics, including opioids and the decreasing nausea and vomiting in the first 24 hours after a laparoscopic sleeve gastrectomy. In an observational series, we found that by performing PG-ANB as the first step in LSG, the need for morphine-equivalent doses and halogenated anesthetics diminished, and hemodynamic stability increased while maintaining the previously reported reduction of postoperative visceral pain and associated symptoms. Similarly, when implementing a variation of the autonomic blockade targeting proper pathways as an early step in cholecystectomy, the same beneficial effects were observed in affected patients.

Study Timeline

• Study First Submitted: 2022-11-26
• Study First Submitted QC: 2022-12-24
• Study First Posted: 2022-12-30
• Study Start: 2023-02-01
• Primary Completion: 2023-04-15
• Status Verified: 2023-05
• Study Completion: 2023-05-01
• Last Update Submitted: 2023-05-07
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

-all adult patients scheduled for LSG at each participating institution.

Exclusion Criteria

• the inability to perform a PG-ANB because of anatomical difficulties
• the need for revisional surgery
• the need for concomitant hiatal hernia repair or other surgical procedures
• conversion to open surgical procedures
• allergies to local anesthetics or medication described in the anesthesia protocol
• intraoperative complications (e.g., visceral or vascular perforations)
• anesthesia-related complications requiring admission to intensive care

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PG-ANB performed at the outset of LSG	PG-ANB performed at the outset of LSG	PG-ANB is performed early in the procedure as a first step before starting the sleeve gastrectomy.
PG-ANB performed at the end of LSG	PG-ANB performed at the end of the LSG	PG-ANB is performed at the end of the sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
Intraoperative consumption of the halogenated agent (sevoflurane)	duration of the anesthesia	The anesthetic machine will determine the administered amount of sevoflurane (Dräger Primus) which will be reported in ml/min.
Intraoperative Remifentanil consumption	duration of the anesthesia	The amount of remifentanil administered will be calculated based on the amount of the consumed mix and reported as total mcg and mcg/kg/min.

Secondary Outcome Measures

Name	Time	Method
recovery from anesthesia measured by the Modified Aldrete Scale	one hour after surgery	The Modified Aldrete scale from 0 to 15 (a higher score correlates with better recovery from anesthesia) will be assessed and recorded 15 minutes and 1 hour after surgery.

Trial Locations

Locations (1)

clinicas Portoazul e Iberoamerica; 🇨🇴 Barranquilla, Atlantico, Colombia